Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol

Trial Information

Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol

Purpose and Description:

The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection
medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a
similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients
receiving their first or second kidney transplant from cadaver or living donors.

Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day,
each in two divided doses (induced with either the IL-2 receptor inhibitors or
thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml.
Methylprednisolone is to be given as per our center protocols, weaning to dose levels of
<0.1 mg/kg by 3-6 months post-operatively.

Inclusion Criteria:

1. Patient has been fully informed and has signed a dated IRB approval informed consent
form and is willing to follow study procedures for the extent of the study (12
months). Parent or legal guardian must provide written consent for patients <18
years of age.

2. Age 18-75 years.

3. Weight > 40 kg.

4. Primary or secondary renal allograft: living or deceased donor.

5. Negative standard crossmatch for T cells.

6. Women of childbearing potential will be required to have a negative qualitative serum
pregnancy test and agree to use an adequate method of contraception for the study
duration.

7. Males and females are to be studied equivalently as they become available for
transplantation using these criteria.

Exclusion Criteria:

1. Patient has previously received or is receiving an organ transplant other than a
kidney.

4. Patient has a current malignancy or a history of malignancy (within the past 5
years), except non-metastatic basal or squamous cell carcinoma of the skin that has
been treated successfully, or carcinoma in situ of the cervix that has been treated
successfully.

5. Patients with significant liver disease, defined as having during the past 28 days
continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the
upper value of the normal range of this center.

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